Wednesday, May 2, 2018

Seasoned Scientific Experts and Strategic Pharmaceutical Industry Veterans Join Cerenis’ Scientific Advisory Board in Oncology

TOULOUSE, France & LAKELAND, Mich.–(BUSINESS WIRE)–Regulatory News:

CERENIS Therapeutics (Paris:CEREN) (FR0012616852 – CEREN – PEA-PME
eligible)
, an international biopharmaceutical company dedicated to
the discovery and development of HDL-based innovative therapies for
treating cardiovascular and metabolic diseases, as well as new HDL-based
vectors for targeted drug delivery in the field of oncology, announces
the creation of its Scientific Advisory Board in Oncology (SAB-Oncology)
with five key appointments: Briggs Morrison, MD, who will
serve as the Chairman of the SAB, Mark Frohlich, MD, Aurélien
Marabelle
MD, PhD, Robert Schneider, PhD and Robert J.
Spiegel
, MD, FACP.

Jean-Louis Dasseux, founder and CEO of Cerenis, commented: “Cerenis
is fully committed to implement its strategy in targeted HDL drug
delivery. Creating this SAB in Oncology represents another important
step forward for the company following the asset acquisition of Lypro
Biosciences. More steps will follow as the company is leveraging its
leading expertise in HDL, its intellectual property, its unique
large-scale recombinant human apoA-I and HDL manufacturing and its
clinical experience in HDL development to create a unique HDL drug
delivery platform. Cerenis intends to develop products based on HDL drug
delivery to allow for selective targeting to effectively kill cancer
cells while protecting normal tissues. We are very happy to have such
prestigious leading experts bringing not only a wealth of experience
across research and clinical development, but also a hands-on experience
in pharmaceutical and drug development strategies. This is essential to
guide us in prioritizing and driving forward our drug delivery platform
and clinical programs in Immuno-oncology and Chemotherapy.”

Briggs Morrison, MD, SAB Chairman, commented“I
am very enthusiastic about joining Cerenis’ Oncology Scientific Advisory
Board to help the company develop promising new products for
Immuno-oncology and Chemotherapy, and to help the Cerenis management
understand this exciting but complex field. Targeted drug delivery has
always been a ‘holy grail’ in Oncology and Cerenis may be at the point
where such a challenge can be overcome with novel HDL technology
developed by the company. For the first time we have pharmaceutical
grade HDL, that may act as a universal carrier for diverse payloads
including antigens, nucleic acids, and chemotherapeutic agents with a
high specificity toward the targeted cells.”

Mark Frohlich, MD, SAB member, commented: “The concept of
targeted delivery to cancer using nanoparticles is highly attractive.
However, historical nanoparticle platforms, such as liposomal
formulations, have failed to deliver on their promise. Challenges have
included difficulties in manufacturing a consistent product, poor in
vivo stability, and highly inefficient tumor targeting. The Cerenis HDL
platform holds great potential to overcome these challenges and deliver
on the promise of targeted nanoparticle delivery.”

The SAB-Oncology will work closely with Cerenis’ management team as it
develops its targeted HDL drug delivery platform in immuno-oncology and
chemotherapy and it is actively preparing to bring a lead product
candidate into clinical studies. The Company believes its targeted HDL
drug delivery platform has the potential to transform the treatment
paradigm in immuno-oncology and chemotherapy, a market representing more
than $30 billion. Cerenis is positioned to leverage its considerable IP
positions and manufacturing expertise to make unique contributions in
this important therapeutic space.

Briggs Morrison, MD: Chairman of Cerenis’ SAB Oncology – Former
Head of Global Medicines Development and Chief Medical Officer at
AstraZeneca

Briggs W. Morrison received his B.S. in biology from Georgetown
University, his M.D. from the University of Connecticut Medical School,
completed residency training in Internal Medicine at the Massachusetts
General Hospital, and completed a fellowship in Medical Oncology at the
Dana-Farber Cancer Institute. He did post-docs with Dr. Philip Leder at
Harvard Medical School, and Dr. Lee Nadler at the Dana-Farber Cancer
Institute. He joined Merck & Co., Inc. in 1995, where he held various
R+D positions including leading the Clinical Oncology Department.
Subsequently he was appointed Head of Clinical Development at Pfizer in
2007, and became the Head of Global Medicines Development and Chief
Medical Officer at AstraZeneca in 2012. He is currently the CEO of
Syndax Pharmaceuticals.

Dr. Morrison has overseen the development of numerous biopharmaceutical
products in multiple therapeutic areas, from First-In-Human trials
through to global regulatory approvals. He is currently a Board member
of private companies Oncorus and Repare Therapeutics, and is an advisor
to a number of other private biotechnology companies. In addition, Dr.
Morrison is a Board member of the Alliance for Clinical Research
Excellence and Safety (ACRES), a non-profit organization dedicated to
optimizing the global clinical research system.

Mark Frohlich, MD – Former Executive V.P. of Portfolio Strategy at
Juno Therapeutics

Dr. Mark Frohlich has been involved in the development of cellular
immunotherapies for cancer for more than 15 years. He was recently EVP
of Portfolio Strategy at Juno Therapeutics, prior to its $9 billion
acquisition by Celgene. He previously served as EVP of R&D and Chief
Medical Officer of Dendreon Corporation, where he led the clinical team
responsible for the approval of the first cellular immunotherapy in the
US and Europe (Provenge®). Prior to that he led the clinical team at
Xcyte Therapies, developing autologous activated T cells for cancer. Dr.
Frohlich is a medical oncologist. He is a graduate of Harvard Medical
School and Yale College.

Aurélien Marabelle, MD, PhD – Clinical Director of the Cancer
Immunotherapy Program at Gustave Roussy Cancer Center

Dr. Aurélien Marabelle’s clinical practice is dedicated to early phase
clinical trials in Cancer Immunotherapy. His translational research is
focused on mechanisms of action of immune checkpoint monoclonal
antibodies. He works as a senior medical oncologist and an investigator
in the Drug Development Department (DITEP) directed by Dr. Christophe
Massard. He is coordinating a team focusing on cancer immunotherapy
translational research projects in the INSERM U1015 lab directed by Prof
Laurence Zitvogel. Dr. Marabelle is a member of ESMO, ASCO, EATI and
AACR.

Robert Schneider, PhD – Albert Sabin Professor of Molecular
Pathogenesis, Professor of Radiation Oncology

Dr. Robert Schneider is associate Director of the NYU Cancer Institute,
Director of Translational Cancer Research, and Co-director of the Breast
Cancer Research Program at NYU School of Medicine.

He is also the Associate Dean for NYU Technology Ventures and
Partnerships, which has transformed NYU’s technology transfer and
commercialization into a leading therapeutics development and new
company academic enterprise. Dr. Schneider is also an active researcher,
and performs basic, translational, and clinical research on the
molecular basis of metastatic breast and ovarian cancers,
interconnections with the inflammatory response, and the development of
new therapeutics. He is the author of more than 160 peer-reviewed
publications. He has received a number of awards in recognition for his
achievements, including the 2012 Susan E. Donelan Hope for the Future
Award for breast cancer research from the Dana Farber Cancer Institute;
the 2011 Distinguished Alumnus Award & Commencement address from the
University of Delaware; the 2010 Judah Folkman Memorial lecture from the
Chemotherapy Society, among others. Dr. Schneider is a co-founding
scientist of six biotechnology/small pharmaceutical companies including
ImClone Systems (New York), PTC Therapeutics (New Jersey), Canji (San
Diego), Gencell (Paris) and ENB Therapeutics (New York). Dr. Schneider
received his Ph.D. in biomedical sciences from the Mount Sinai School of
Medicine and was a postdoctoral research fellow in the Department of
Molecular Biology at Princeton University.

Robert Spiegel, MD – Former Sr. V.P. for worldwide Clinical
Research and Chief Medical Officer at Schering-Plough

Dr. Spiegel has over 30 years of extensive R&D and operational
experience in biopharmaceuticals including Big Pharma, biotech, and
academic startups as well as interactions advising venture capital and
private equity.

Dr. Spiegel spent over 25 years at Schering-Plough where he joined as
the first Director for Oncology Clinical Research, and subsequently held
a series of senior executive positions, including Senior Vice President
for worldwide Clinical Research and Chief Medical Officer. During his
time at Schering-Plough he took numerous drug candidates through
clinical development and was involved with over 30 NDA approvals at the
FDA. For the last five years Dr. Spiegel has been a consultant to the
biotech industry and has served on the Boards of multiple biotech
companies He currently serves on the Boards of Directors of Geron Corp,
Edge Therapeutics, and Neximmune Inc. and is Chairman of Vidac
Therapeutics. He is currently the principal of Spiegel Consulting LLC
and an Assistant Professor of Medicine at Weill Cornell Medical College.
He is also a Senior Advisor to private equity firm Warburg Pincus and an
Advisor to the Israel Biotech Fund.

Dr. Spiegel received his B.A. from Yale University and his M.D. from the
University of Pennsylvania. He completed his specialty training at the
National Cancer Institute, National Institutes of Health (NIH).

About CERENIS: www.cerenis.com

CERENIS Therapeutics is an international biopharmaceutical company
dedicated to the discovery and development of innovative therapies for
the treatment of cardiovascular and metabolic diseases. HDL is the
primary mediator of the reverse lipid transport, or RLT, the only
natural pathway by which excess lipids is removed from arteries and is
transported to the liver for elimination from the body.

CERENIS is developing a portfolio of lipid metabolism therapies,
including HDL mimetics for patients with genetic HDL deficiency, as well
as drugs which increase HDL for patients with a low number of HDL
particles to treat atherosclerosis and associated metabolic diseases
including Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic
Steato-Hepatitis (NASH). Capitalizing on its expertise, Cerenis is
developing the first HDL-based targeting drug delivery platform
dedicated to the oncology field (immuno-oncology and chemotherapy).

CERENIS is well positioned to become one of the leaders in the HDL
therapeutic market, with a broad portfolio of programs in development.

About Targeted HDL Drug Delivery

HDL particles, loaded with an active agent, hold the promise to target
and selectively kill malignant cells while sparing healthy ones. A wide
variety of drugs can be embedded in these particles targeting markers
specific to cancer cells and bring these potent drugs to their intended
site of action, with lowered systemic toxicity. Cerenis intends to
develop the first HDL-based targeting drug delivery platform dedicated
to the oncology market, including immuno-oncology and chemotherapy.

Financial Agenda:
Annual Shareholder Meeting: June 25th,
2018

Source link

No comments:

Pharmaceutical Validation Documentation Requirements

Pharmaceutical validation is a critical process that ensures that pharmaceutical products meet the desired quality standards and are safe fo...